Drug
Who makes glycerol phenylbutyrate?
7 companies list glycerol phenylbutyrate as a human prescription drug, including under the names Ravicti. Forms: liquid. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing glycerol phenylbutyrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Lupin LimitedIndia | liquid | NDANDA203284 | 1 | 14 |
| Aurobindo Pharma LimitedIndia | liquid | ANDAANDA220313 | 1 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | liquid | ANDAANDA218738 | 1 | 6 |
| Horizon Pharmaceuticals , Inc.United States | liquid | NDANDA203284 | 1 | 1 |
| Navinta LLCUnited States | liquid | ANDAANDA220568 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | liquid | ANDAANDA220568 | 1 | 1 |
| Novadoz Pharmaceuticals LLC | liquid | ANDAANDA219540 | 1 | 0 |
Bulk ingredient listings
- HAS Healthcare Advanced Synthesis SASwitzerland · 2 NDC
- APOTHECON PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- Lupin LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- Patheon Austria GmbH & CoKG · 1 NDC
Orange Book patents
14 unexpired patents list glycerol phenylbutyrate as the active ingredient, expiring between Sept 2030 and Sept 2030. Application holder: HORIZON THERAPEUTICS US HOLDING LLC.
Enquiry
Common questions
- Who makes glycerol phenylbutyrate?
- 7 companies list glycerol phenylbutyrate as a human prescription drug in the openFDA NDC Directory, led by Lupin Limited, Aurobindo Pharma Limited, Teva Pharmaceutical Industries Ltd., Horizon Pharmaceuticals , Inc., Navinta LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Ravicti?
- 5 companies list glycerol phenylbutyrate under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies glycerol phenylbutyrate active ingredient?
- 8 companies list glycerol phenylbutyrate as a bulk ingredient, including HAS Healthcare Advanced Synthesis SA, APOTHECON PHARMACEUTICALS PRIVATE LIMITED, Aurobindo Pharma Limited, Hetero Drugs Limited.